Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Agfa Healthcare NX 3.0.8950 Imaging Processing Software Recalled by AGFA Healthcare Corp. Due to A customer reported that when using an NX...

Date: December 21, 2016
Company: AGFA Healthcare Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AGFA Healthcare Corp. directly.

Affected Products

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

Quantity: 221 units

Why Was This Recalled?

A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.

Where Was This Sold?

This product was distributed to 34 states: AL, AZ, AR, CA, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV, DC

Affected (34 states)Not affected

About AGFA Healthcare Corp.

AGFA Healthcare Corp. has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report